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Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling

NCT ID: NCT04338295

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-09

Study Completion Date

2022-05-16

Brief Summary

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The investigators propose to study the efficacy of micro-needling via the SOL Nova Device in generating hair growth in patients with Alopecia Areta (AA) who are either non-responsive or only partially responsive to combination oral JAK inhibitor plus oral minoxidil therapy.

Detailed Description

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This will be a trial evaluating the efficacy of micro-needling via tattoo device in stimulating scalp hair growth in patients with AA refractory to combination JAK inhibitor and oral minoxidil treatment. Ten healthy subjects who are at least eighteen years of age who have experienced no or partial scalp hair regrowth after ≥three months of JAK inhibitor plus oral minoxidil treatment will be enrolled. Subjects will undergo a treatment session once every thirty days for a total of six sessions over six months and will complete a total of eight visits over eight months. Procedures and visits are not standard of care but conducted for research. Each visit will last about an hour. Approximately 30 minutes will be spent on consenting and time for patient to ask questions during the first visit. The remaining 30 minutes will be allotted for the investigator to determine if the patient meets criteria for trial enrollment. During the remaining visits, 20 minutes will be allotted for photography, 15-20 minutes for the procedure and 10-15 minutes for post-procedure patient assessment. Remaining 10 minutes on visits 2 and 8 will be used for biopsy.

Conditions

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Alopecia Areata

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Microneedling

Participants with Alopecia Areata will receive microneedling with a tattoo machine.

Group Type EXPERIMENTAL

Tattoo machine (SOL Nova Device)

Intervention Type DEVICE

A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.

Interventions

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Tattoo machine (SOL Nova Device)

A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of AA
* SALT score ≥90%
* No or minimal scalp hair regrowth after ≥three months of oral JAK inhibitor plus oral minoxidil treatment

Exclusion Criteria

* Known concomitant androgenetic or other form of alopecia (in addition to AA)
* Patients with the following who would make poor candidates for microneedling such as skin conditions, diabetes, or history of keloid formation
* Anything additional existing comorbidities that in the opinion of the investigator may cause unnecessary risk for the patient to participate
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brett King, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Dermatology, Yale University

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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2000027352

Identifier Type: -

Identifier Source: org_study_id